A German drug-monitoring study in general practice patients receiving cisapride for functional dyspepsia.

An open prospective drug monitoring study was undertaken to assess the efficacy and tolerability of 5 mg cisapride three times daily in 37,925 general practice patients with functional dyspepsia. Short-term (mean, 4 weeks) cisapride treatment was associated with a significant reduction in overall dyspeptic symptom scores and improvements in scores of all eight individual dyspeptic symptoms (epigastric discomfort, fullness, nausea, bloating, heartburn, acid regurgitation, loss of appetite, and vomiting). Physician's and patient's subjective global evaluations of antidyspeptic efficacy were good or very good in 80% to 90% of cases. The tolerability of cisapride was judged to be satisfactory, good or very good in approximately 95% of patients, with adverse drug reactions being documented in 4.8% of patients. Of these, diarrhea/loose stools (2.5% of all patients) and headache (0.7%) were most frequent. Premature treatment withdrawal due to poor tolerability was necessary in only 0.35% of patients.